Essential Duties and Responsibilities
• Lead the clinical outsourcing process and work with the clinical operation teams to deliver robust agreements.
• Ensure that contracts maximize value, while minimizing risk across broad scope of clinical outsourcing services as well as regional, regulatory and legal requirements.
• Actively contribute to the development and implementation of sourcing strategies for R&D non-clinical and clinical supplies and Contract Research Organization (CRO) services.
• As a single point of contact, proactively work with Tolmar functional teams in R&D to identify scope of contract services required suitability of supplier identification requirements in advance of supplier and CRO Requests for Proposal communications.
• Develop detailed specifications and prepare, finalize, and distribute Requests for Proposal (RFP) to vendors with a team of internal stakeholders.
• Lead and support the supplier and CRO selection process, including the selection of transactional and preferred vendors, for designated programs and/or clinical/non-clinical supplies and services.
• Manage the receipt and internal distribution of vendor responses and, as appropriate, review proposals, conduct bid evaluation analyses, coordinate bid defenses with the suppliers.
• Negotiate master service and quality agreements, confidentiality, service standards, and other vendor agreements.
• Proactively support vendor cost and service agreement activities that are conducted on time, in budget and with high quality.
• Develop and foster relationships with preferred/alliance suppliers to ensure clear communication, create an environment of partnership, and agreed-to contractually committed levels of service, quality, timely delivery and cost.
• Collaborate in the development and implementation of multi-year strategies to align Tolmar’s most significant suppliers and CRO services with the global R&D development plans.
• Interact with the Legal, Finance, and other departments, as needed, to ensure cross departmental alignment with respect to processes and policies for contract development, approval, execution and management.
• Manage changes in contract scope, change orders, and amendments to ensure accurate and timely revisions to terms and/or services.
• Document and maintain a comprehensive category profile for R&D service categories, as assigned.
• Achieve significant synergies and cost savings for R&D budgets for supplies and clinical CRO services.
• Perform other related duties as assigned.
Requirements Knowledge, Skills & Abilities
• Demonstrated ability to lead the development of contract negotiations and management processes.
• Excellent ability to communicate effectively with executives and senior leaders, both internally and externally.
• Proven experience within pharmaceutical or contract research industry along with knowledge and understanding of clinical development process and clinical research experience.
• Financial analysis experience including a proven track record of budget management, contract financial analysis, evaluation of pricing models and negotiation of the financial aspects of contracts.
• Excellent business/financial acumen, proficient in leading and managing cross-functional teams.
• Ability to lead, motivate, influence and drive change at all levels of the organization.
• Ability to understand the factors affecting the finances and/or operations of suppliers.
• Excellent global supplier management skills with ability to foster and leverage professional relationships.
• Ability to identify and solve complex contractual, process, operational business challenge, and know when to seek assistance.
• Clear understanding of clinical and non-clinical R&D suppliers, CRO services and pharmaceutical sponsor responsibilities, financial drivers and competencies.
• Demonstrated ability to drive change and challenge the status quo.
Education & Experience
• Bachelor’s Degree in Business or related discipline. Master’s Degree preferred.
• Five or more years’ direct experience in a negotiating and managing nonclinical and clinical supply and/or service agreements, and other responsibilities within the pharmaceutical industry.